Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.
The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.
Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?
Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
A novel screening test is changing the way tuberculosis is detected and controlled, thanks in part to a custom shipping solution from American Aerogel.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.
The life science industries face the challenge of delivering safe and cost-effective products on time, every time. The pressure to put products into the marketplace is undoubtedly intensified by the strict guidelines enforced by the FDA and other regulatory bodies worldwide.
Cancer continues to be a formidable disease with an overall success rate of bringing new drugs to market of only 5-8%.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
The importance of optimizing the chemical synthesis and formulation processes in complex molecule development.
To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help. At a CPhI North America panel on single-source CDMOs, four industry experts discussed how working with a single-source CDMO partner can accelerate time to market, add cost savings, and improve a formulation’s chances of achieving regulatory success.
